Use of Ultrasound to Evaluate Clavicle Fractures in Pediatric Patients

This study has been completed.
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00652548
First received: March 28, 2008
Last updated: January 12, 2010
Last verified: March 2008
  Purpose

This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.


Condition
Fractures

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs [ Time Frame: Single visit to emergency department ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unblinded real-time bedside US by the ED physician vs. radiographs [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]
  • Interoperator reliability between the blinded reviewer and bedside ED physician [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]
  • FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs [ Time Frame: Single ED visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children age 1-18 years presenting to a tertiary center pediatric emergency department complaining of recent traumatic shoulder injury.

Criteria

Inclusion Criteria:

  • Age 1-18 years
  • Pain from recent shoulder/clavicle injury
  • Intact neurovascular exam
  • Radiographs performed as part of normal ED evaluation

Exclusion Criteria:

  • Hemodynamic instability
  • Multisystem trauma
  • Altered mental status
  • Open wounds to injured shoulder
  • Developmental delay
  • Prior radiographs at another clinic/hospital for this injury
  • Previous clavicle fracture on the affected side
  • Ultrasound gel allergy
  • Non-English-speaking parents/child (unable to give informed consent)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652548

Locations
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Keith P Cross, MD University of Louisville
  More Information

No publications provided

Responsible Party: Keith Cross, Kosair Children's Hospital, Dept. of Pediatrics, Division of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00652548     History of Changes
Other Study ID Numbers: 08-0007, IRB #08-0007, NHRO #1310
Study First Received: March 28, 2008
Last Updated: January 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Louisville:
Clavicle
Fracture
Ultrasound
Radiation

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on July 24, 2014